BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BETA C COUNTER

    K Number: K943072 · Decision Sep 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    93

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    Basic Information

    Device Name
    BETA C COUNTER
    K Number
    K943072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Capintec Instruments, Inc.
    Date Received
    June 28, 1994
    Decision Date
    September 29, 1994
    Product Code
    KPT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPT Calibrator, Dose, Radionuclide

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